Lakewood-Amedex Biotherapeutics Inc., a clinical‑stage biotechnology company listed on NASDAQ under LABT, announced the first patient dosing in its Phase 2a trial of Nu‑3, a topical antimicrobial gel derived from the company’s Bisphosphocin platform.
The multicenter, single‑blinded study, conducted with the Professional Education and Research Institute LLC, evaluates three gel concentrations—2%, 5% and 10%—in adult patients with mildly infected diabetic foot ulcers associated with Type 1 or Type 2 diabetes. The trial’s primary objectives are to assess safety, reduce microbial burden and demonstrate infection resolution.
Chief Medical Officer Thomas Balzer said the dosing marks a key milestone for the program. The study is designed as a dose‑finding effort, with topline results anticipated in the first quarter of 2027. Upon completion, the program plans to move to a Phase 2b trial that will compare once‑daily and twice‑daily dosing regimens against placebo.
The trial is being run at multiple sites under the oversight of podiatrist Charles Zelen, who leads the CRO. Lakewood‑Amedex is headquartered in Sarasota, Florida.
